Cleared Traditional

K840745 - STERILE ABSORBENT GAUZE BURN & SOUND

K840745 · Chesebrough-Pond'S U.S.A. Co. · General & Plastic Surgery device
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Apr 1984
Decision
61d
Days
-
Risk

K840745 is an FDA 510(k) clearance for the STERILE ABSORBENT GAUZE BURN & SOUND. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Chesebrough-Pond'S U.S.A. Co. (Walker, US). The FDA issued a Cleared decision on April 23, 1984 after a review of 61 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Chesebrough-Pond'S U.S.A. Co. devices

Submission Details

510(k) Number K840745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1984
Decision Date April 23, 1984
Days to Decision 61 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 115d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 197
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